Problem with Draeger transport ventilators categorized as Class I recall by FDA

Draeger contacted customers last month after receiving reports that devices stopped providing ventilation because of depleted batteries.

By Nick Paul Taylor • July 14, 2023

Urotronic wins FDA approval to challenge Boston Scientific, Teleflex for prostate market

The company’s Optilume device combines balloon dilation and the delivery of paclitaxel to treat symptoms linked to an enlarged prostate. 

By Nick Paul Taylor • July 13, 2023

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Illumina hit by EU with maximum €432M fine for Grail acquisition

The European Commission called Illumina’s closing of the deal without its approval an “unprecedented” move that undermines its system for regulating the competitive landscape.

By Susan Kelly • July 12, 2023

Analysis shows paclitaxel-coated devices unlikely to increase death risk, leading FDA to withdraw warning

The FDA’s decision to remove mortality warnings from device labels is a boost to manufacturers of paclitaxel-coated devices.

By Nick Paul Taylor • July 12, 2023

J&J Megadyne unit’s electrode pad recall labeled Class I over burn risk

The problem, which can cause third-degree burns, has been linked to 63 injuries and no deaths.

By Nick Paul Taylor • July 12, 2023

Analysts expect a reimbursement boost for Shockwave coronary artery-clearing device

The analysts think growth expectations for the company are too low and have set their earnings estimate for next year 15% above Wall Street’s consensus.

By Nick Paul Taylor • July 11, 2023

Medtronic secures Medicare coverage for MiniMed 780G insulin pump

Medtronic has begun processing orders and will start shipping devices over the next few weeks.

By Nick Paul Taylor • July 10, 2023

European guidelines offer support for renal denervation in hypertension, boosting Medtronic, ReCor

Medtronic hailed the updated guidelines as a “turning point” for the use of renal denervation in treating high blood pressure.

By Nick Paul Taylor • July 6, 2023

Startup’s fast-acting wound treatment gel gets FDA nod for use in humans

Cresilon raised $25 million last year as part of a push to expand its wound-gel product for animals into human health.

By Nick Paul Taylor • July 5, 2023

EU MDR costs could cause device shortages for children, medical groups warn

The cost of certification under new medical device regulations in Europe is a barrier to manufacturers that make devices for small groups of patients, medical associations said.

By Elise Reuter • June 29, 2023

FDA seeks feedback on technologies that can enable healthcare at home

The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.

By Nick Paul Taylor • June 29, 2023

FDA repeats restrictions on NuVasive limb-lengthening device after clearing pediatric use

The agency in March cleared NuVasive to market its Precice limb-lengthening system for use in the femur and tibia of children aged 12 years and up.

By Nick Paul Taylor • June 29, 2023

FTC proposes updates to merger review that could slow healthcare dealmaking

A new rule proposed by antitrust regulators would ask companies to provide additional information about planned mergers to help the Federal Trade Commission keep pace with increased deal volume and complexity.

By Emily Olsen • June 28, 2023

Teleflex recall of separating vascular catheters labeled Class I event

The company began the recall in May after receiving 83 complaints, including 18 reports of injuries, related to the fault.

By Nick Paul Taylor • June 28, 2023

Proposed EtO limits garner criticism from device industry, praise from occupational health groups

Lobbyists representing medical device companies say the proposed policy would reduce capacity at commercial sterilizers by as much as 50%.

By Elise Reuter • June 27, 2023

CMS proposes pathway to earlier breakthrough device coverage

The voluntary plan would allow manufacturers to address evidence gaps through studies designed to answer specific questions.

By Susan Kelly • Updated June 23, 2023

Owlet receives FDA clearance for prescription pulse oximetry baby sock

Clearance of the new system settles a controversy that began last year when Owl sold a similar pulse oximetry device over the counter, but was ordered to pull it from sale and seek regulatory approval as a medical device.

By Nick Paul Taylor • June 22, 2023

Proposed breast cancer screening recommendations don’t go far enough

A proposal by a government-sponsored task force calling for a 24-month spacing between mammograms fails to address the latest research and may further exacerbate disparities and mortality outcomes, argues Henry Izawa, head of FujiFilm Healthcare Americas.

By Henry Izawa • June 21, 2023

The importance of trust in AI as a medical device

Building trust with patients, as well as regulators, will be key to the adoption of AI in medical devices and diagnostics, argues Alison Dennis, a London-based partner with law firm Taylor Wessing.

By Alison Dennis • June 15, 2023

Huma hails 510(k) clearance as boost to digital health product development

The clearance permits Huma to host digital health tools from multiple creators that support screening, diagnosis, dosing recommendations and clinical decisions.

By Nick Paul Taylor • June 13, 2023

EPA’s proposed ethylene oxide regulations may cost sterilizers more than estimated: Moody’s

Large commercial sterilizers should be able to handle the increased costs, but smaller companies might have to sell, Moody’s analysts write. 

By Elise Reuter • June 9, 2023

Cue Health wins first non-emergency authorization for COVID test, days after Goldman downgrade

The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.

By Peter Green • June 7, 2023

FDA: iRhythm targeted heart monitor at ‘high-risk’ patients without seeking clearance

William Blair analysts believe “customers are unlikely to change their usage of Zio AT [heart monitors] over time, making this a resolvable issue.”

By Nick Paul Taylor • June 7, 2023

Abiomed heart pump recall labeled Class I by FDA, no deaths reported

The recall, tied to specific sets of the Impella 5.5 with SmartAssist, comes just months after Johnson & Johnson paid $16.6 billion for Abiomed.

By Peter Green • Updated June 5, 2023

AdvaMed lobbies for medtech companies to be prioritized in global supply chain

The medtech trade group published a white paper outlining supply chain improvements needed to ensure availability of materials and parts for medical devices.

By Elise Reuter • June 2, 2023